Neuromodulation device

Abstract

This disclosure provides an apparatus or system for the modulation of neural activity in the cervical sympathetic chain (CSC) or superior cervical ganglion (SCG) or SCG post-ganglionic branch(es) and for the treatment of sleep apnoea, as well as methods for their use.

The invention claimed is: 
     
       1. An apparatus for treating sleep apnea in a subject, the apparatus comprising:
 i. at least two implantable neural interfacing elements each having one or more electrodes configured to deliver at least two independently selected electrical signals, wherein one neural interfacing element is configured to be in signaling contact with at least one of a left cervical sympathetic chain (CSC), a left superior cervical ganglion (SCG) or postganglionic branch thereof and wherein one neural interfacing element is configured to be in signaling contact with at least one of a right cervical sympathetic chain (CSC), a right superior cervical ganglion (SCG) or postganglionic branch thereof; and 
 ii. a controller operably coupled to the at least two implantable neural interfacing elements, the controller programs the at least two implantable neural interfacing elements to deliver the electrical signals that increase localized sympathetic activity of the left CSC, left SCG or postganglionic branch thereof and the right CSC, the right SCG or postganglionic branch thereof, wherein the controller causes the at least two implantable neural interfacing elements having the at least one or more electrodes, which are positioned bilaterally, with one neural interfacing element placed on a left side of the subject and one neural interfacing element placed on a right side of the subject, to deliver the independently selected electrical signals to cause improvements in different parameters, 
 wherein increased sympathetic activity of at least one of the CSC, SCG or postganglionic branch ameliorates sleep apnea in the subject. 
 
     
     
       2. The apparatus of  claim 1 , wherein at least one of the one or more electrodes is a cuff electrode. 
     
     
       3. The apparatus according to  claim 1 , wherein one of the independently selected signals is initiated at a first frequency and then altered to a second frequency, wherein (a) the first frequency is higher than the second frequency; or (b) the first frequency is lower than the second frequency. 
     
     
       4. The apparatus according  claim 1 , wherein the controller is configured to cause at least one of the independently selected signals to be delivered intermittently. 
     
     
       5. The apparatus according to  claim 4 , wherein the controller causes at least one of the independently selected signals to be delivered for a first time period, then stopped for a second time period, then reapplied for a third time period, then stopped for a fourth time period, wherein a duration of each of the first, second, third and fourth time periods is independently selected from: 0.8 s-2 min, 0.8 s-30 s, 0.8 s-10 s, 0.8 s-5 s, 0.8-2 s, 10 s-2 min, 30 s-2 min, and 30 s-1 min. 
     
     
       6. The apparatus according to  claim 1 , wherein the increase in localized sympathetic activity in at least one of the CSC, SCG or postganglionic branch thereof produces one or more of: a decrease in duration of apneic episodes, a decrease in frequency of apneic episodes, a decrease in blood pressure, a decrease in respiratory rate, an increase in tidal volume, a decrease in upper airway resistance, an increase in diaphragmatic muscle activity, an increase in genioglossus muscle activity, and an increase in central respiratory drive. 
     
     
       7. The apparatus according to  claim 1 , wherein the increase in localized sympathetic activity in at least one of the CSC, SCG or postganglionic branch thereof results in at least one of an increase in tidal volume, a decrease in upper airway resistance, an increase in diaphragmatic muscle activity and an increase in genioglossus muscle activity. 
     
     
       8. The apparatus according to  claim 1 , wherein the apparatus further comprises a detector to detect one or more physiological parameters in the subject, wherein one or more of the detected physiological parameters is selected from sympathetic tone;
 diaphragmatic tone; genioglossus tone; blood pressure; respiratory rate; tidal volume; upper airway resistance; and central respiratory drive. 
 
     
     
       9. The apparatus according to  claim 8 , wherein the controller is coupled to the detector, and causes the at least two implantable neural interfacing elements each to apply the independently selected signals when the physiological parameter meets a predefined value. 
     
     
       10. The apparatus according to  claim 1 , wherein the increased localized sympathetic activity as a result of the at least two implantable neural interfacing elements applying the independently selected signals is substantially persistent. 
     
     
       11. The apparatus according to  claim 1 , wherein the increased localized sympathetic activity is temporary. 
     
     
       12. The apparatus according to  claim 1 , wherein the apparatus is suitable for full implantation into the subject. 
     
     
       13. An apparatus for modulating neural activity of at least one of aa CSC, SCG or postganglionic branch of a subject, the apparatus comprising:
 at least two neural interfacing elements comprising one or more electrodes each neural interfacing element configured to apply an independently selected electrical signals wherein one neural interfacing element is t configured to be in signaling contact with at least one of a left cervical sympathetic chain (CSC), a left superior cervical ganglion (SCG) or postganglionic branch thereof and wherein one neural interfacing element is configured to be in signaling contact with at least one of a right cervical sympathetic chain (CSC), a right superior cervical ganglion (SCG) or postganglionic branch thereof; and 
 a controller operably coupled to the at least two neural interfacing elements to provide bilateral stimulation with one neural interfacing element placed on a left side of the subject and one neural interfacing element placed on a right side of the subject, the controller controlling the independently selected signals to be applied by each of the at least two neural interfacing elements, such that the independently selected signals stimulate increased localized sympathetic activity in at least one of the CSC, SCG or postganglionic branch in the subject, and wherein the independently selected signals cause improvements in different parameters. 
 
     
     
       14. The apparatus of  claim 13 , wherein at least one of the one or more electrodes is a cuff electrode. 
     
     
       15. A method for increasing sympathetic activity of a subject comprising:
 implanting in the subject at least a portion of an apparatus for modulating (a) the neural activity of at least one of a left CSC, a left SCG or postganglionic branch of the subject and (b) the neural activity of at least one of a right CSC, a right SCG or postganglionic branch of the subject, the apparatus comprising: 
 i. at least two neural interfacing elements for providing bilateral stimulation, each neural interfacing element -comprising one or more electrodes, wherein one of the at least two neural interfacing elements is configured to apply an independently selected electrical signal to at least one of the left CSC, the left SCG or postganglionic branch thereof of the subject and placed in signaling contact with at least one of the left CSC, the left SCG or postganglionic branch thereof, and further wherein one of the at least two neural interfacing elements is configured to apply an independently selected electrical signal to at least one of a right CSC, a right SCG or postganglionic branch thereof and is placed in signaling contact with at least one of a right CSC, the right SCG or postganglionic branch thereof; and 
 ii. a controller operably coupled to the at least two neural interfacing elements, the controller controlling the independently selected signals to be applied by each of the at least two neural interfacing elements, such that the signals stimulate increased localized sympathetic activity;
 positioning one of the at least two neural interfacing elements of the apparatus in signaling contact with at least one of the left CSC, left SCG or postganglionic branch thereof of the subject;
 positioning one of the at least two neural interfacing elements neural interfacing elements of the apparatus in signaling contact with at least one of the right CSC, right SCG or postganglionic branch thereof of the subject; and 
 
 
 activating the apparatus to cause an improvement in at least two parameters. 
 
     
     
       16. The method according to  claim 15 , wherein the increased localized sympathetic activity ameliorates a condition of sleep apnea in the subject. 
     
     
       17. The method according to  claim 15 , wherein an increase in localized sympathetic activity is indicated by one or more of a decrease in blood pressure, a decrease in respiratory rate, an increase in tidal volume, a decrease in upper airway resistance, an increase in diaphragmatic muscle activity, an increase in genioglossus muscle activity, and an increase in central respiratory drive.